The Berlin Heart Group (Woodlands, Texas/Berlin) unveiled clinical trial data presented yesterday at the "Scientific Sessions 2011" annual meeting of the American Heart Association (AHA; Washington).

Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far. It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and...